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    List of Drug Master Files (DMF) of ATRIPLA Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    26/09/2024 Acebright India Pharma Private Limited
    India
    		 CDYMAX INDIA PHARMA PRIVATE LTD 24847 EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)] 2011-04-08 Active II Complete 2013-12-17 2013-05-08
    26/09/2024 Aurobindo Pharma Limited
    India
    		 APITORIA PHARMA PRIVATE LTD 19932 EFAVIRENZ USP (NON-STERILE DRUG SUBSTANCE) 2006-10-30 Active II N/A